EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial

Stefano Francesco Crinò, Ermina Manfrin, Aldo Scarpa, Francisco Baldaque-Silva, Silvia Carrara, Germana De Nucci, Roberto Di Mitri, Angel Ginés, Julio Iglesias-Garcia, Takao Itoi, Masayuki Kitano, Nam Quoc Nguyen, Pierre H. Deprez, Jan Werner Poley, Vanessa M. Shami, Ilaria Tarantino, Alberto Larghi

Research output: Contribution to journalArticle

Abstract

Background: Rapid on-site evaluation (ROSE)of cytological specimensacquired with EUS-guided fine needle aspiration (EUS-FNA)represents the most accurate available technique to reach a definitive diagnosis in patients with pancreatic solid masses. Recently, needles with high histological yield have been developed for EUS-guided fine needle biopsy (EUS-FNB), with which the need for ROSE can be potentially overcome. Aims: The primary aim is to compare the diagnostic accuracy of EUS-FNB with or without ROSE. The main endpoint will be measured against the gold standard diagnosis (surgical pathology whenever available or diagnostic work-up in agreement with a clinical course of at least six months). Secondary endpoints include: (a)safety; (b)presence of tissue core; (c)quality of specimens; (d)time of the sampling procedure. Reliability of macroscopic on-site evaluation (MOSE)by endosonographers will be also assessed. Methods: FROSENOR is an international randomized non-inferiority ongoing study at sixteen centers in four continents. Eight hundred patients will be randomized in two arms (EUS-FNB + ROSE vs. EUS-FNB alone)and outcomes compared. Sample size has been calculated in order to demonstrate the non-inferiority of FNB alone. Randomization and data collection will be performed online. Discussion: This study will ascertain if ROSE is still needed when performing EUS-FNB of solid pancreatic lesions.

Original languageEnglish
Pages (from-to)901-906
Number of pages6
JournalDigestive and Liver Disease
Volume51
Issue number6
DOIs
Publication statusPublished - Jun 2019

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Keywords

  • Diagnostic accuracy
  • Endoscopic ultrasound
  • Pancreatic cancer

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Crinò, S. F., Manfrin, E., Scarpa, A., Baldaque-Silva, F., Carrara, S., De Nucci, G., Di Mitri, R., Ginés, A., Iglesias-Garcia, J., Itoi, T., Kitano, M., Nguyen, N. Q., Deprez, P. H., Poley, J. W., Shami, V. M., Tarantino, I., & Larghi, A. (2019). EUS-FNB with or without on-site evaluation for the diagnosis of solid pancreatic lesions (FROSENOR): Protocol for a multicenter randomized non-inferiority trial. Digestive and Liver Disease, 51(6), 901-906. https://doi.org/10.1016/j.dld.2019.03.008